- Optimization of an electrolyte system for the simultaneous separation of nelfinavir mesylate and two impurities by micellar electrokinetic chromatography
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A methodology for the simultaneous determination of nelfinavir mesylate and the impurities 3-hydroxy-2-methylbenzoic acid and (2R,3R)-4-((3S,4aS,8aS)-3-(tert-butylcarbamoyl) octahydroisoquinolin-2(1H)-yl)-3-hydroxy-1-(phenylthio)butan-2-aminium benzoate by micellar electrokinetic chromatography, with an analysis time of 25 min, was proposed. An electrolyte composed of sodium tetraborate buffer (pH 9.24; 25 mmol L-1), sodium dodecyl sulphate (9 mmol L-1) and methanol (10percent, v/v) was optimized using a mixed-level factorial design, with direct detection at 200 nm. After evaluating some figures of merit, such as selectivity, linearity, precision, limit of detection, limit of quantification, accuracy and robustness (using Youden's test), the method was successfully applied to the analysis of nelfinavir mesylate and its impurities in a pharmaceutical formulation. The optimized methodology is demonstrated to be useful in the determination of these analytes in a synthesis monitoring process, in raw materials and in pharmaceutical formulations, while offering low solvent consumption, requiring a small sample and using non-specific columns as advantages.
- Bastos, Carina A.,Gomes, Cláudia R. B.,De Souza, Marcus V. N.,De Oliveira, Marcone A. L.
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p. 887 - 898
(2015/05/20)
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- AN IMPROVED PROCESS FOR PREPARATION OF AMORPHOUS NELFINAVIR MESYLATE
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The invention relates to a new improved process to prepare amorphous form of [2S-(3R*, 4aR*, 8aR*, 2'S*, 3'S*)]-2'-[2'-hydroxy-3'-phenylthiomethyl-4'-aza-5'-(2'methyl-3'-hydroxyphenyl)pentyl]decahydroisoquinoline-3-N-tert-butylcarboxamide methanesulfonate
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Page/Page column 6
(2008/06/13)
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- NOVEL CRYSTALLINE FORMS OF NELFINAVIR MESYLATE
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The present invention provides novel crystalline forms of Nelfinavir mesylate, Form-A, Form-B, Form-C, Form-D and the process for their preparation without the use of any special equipment such as a spray drier, avoiding the use of highly flammable solven
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Page/Page column 6
(2008/06/13)
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- Method of making a HIV-Protease inhibitor
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The present invention is directed to a method of making the HIV-protease inhibitor nelfinavir mesylate.
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Page/Page column 30
(2010/11/30)
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- Production of amide derivatives and intermediate compounds therefor
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A method for producing an amide derivative of the formula ?XV! STR1 wherein each symbol is as defined in the specification, and an enantiomer thereof, a novel intermediate useful for producing said compound and a production method thereof. The production method of the present invention is extremely easy and simple as compared to the conventional methods, and enables effective production of compound ?XV! at high yields, which includes compound ?XVI! having an HIV protease inhibitory action. In addition, the novel intermediates of the present invention are extremely useful as intermediates for producing not only the aforementioned compound ?XVI! but also compounds useful as X-ray contrast media.
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